The Institutional Review Board (IRB) is a
campus committee empowered by federal regulations to oversee
research activities involving human subjects. The IRB is
responsible for the review and monitoring of research involving
human subjects in order to assure the protection of the rights
and welfare of the subjects participating in research. The IRB
is dedicated to facilitating the ethical conduct of research.

The IRB is comprised of faculty and community
members. The current list of IRB members may be found on the IRB
website. As of August 25, 2010, all applications to the IRB must
be submitted via IRBNet. Please consult our home page to obtain
instructions.

If your project involves research with human subjects, it
needs to be reviewed by the IRB. Often investigators only consider
traditional biomedical research studies as needing IRB review,
however, legal requirements to protect human subjects apply to a
much broader range of research. Examples include:

Data collected through intervention or
interaction with individuals.

Intervention and interaction includes not
only physical procedures (like drawing blood)
but also interviews, observations, surveys,
tests, manipulation of a subject's environment,
and taste test options.

Existing data or records of individuals, even
if the information was not collected specifically
for the study in question.

Bodily materials such as cells, blood,
urine, tissues, organs, hair, or nail clippings,
even if you did not collect these materials.

As stated in the federal
regulations (45 CFR 46.102)

Research-means a systematic
investigation, including
research development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.

Human Subject-means a living
individual about whom
an investigator (whether professional or
student) conducting research obtains:

Data through intervention or
interaction with the individual, or

Identifiable private
information.

If you are unsure if your project meets the definition of research or human subject, please refer to the "Is It Research?" tool on the IRB website or contact the IRB Administrator at
ISU-IRB@indstate.edu

3. I have a research study that needs to be reviewed. What do I need to do?

As of August 25, 2010, all research
studies needing IRB review MUST be submitted via IRBNet, which can be accessed
at www.irbnet.org .Visit the IRB Web site for instructions for registering and
using IRBNet to submit your study. Please refer to the checklists,
provided in the IRBNet "Forms and Templates" library, for a list of items to be submitted with your application.
You will also need to complete the required
training in human subjects protections prior to
submitting your application.

Informed consent assures that potential subjects understand
the nature of the research and their participation and can make
an informed, voluntary decision about participating or not
participating in the research project. Informed consent is an
ongoing process, not just a form that is signed.

Consent documents must be clearly written in second person
(e.g., you are asked to participate...) and at a reading level
appropriate for your potential subjects. Any scientific or
technical terms must be plainly defined using nontechnical
language.

A checklist of required informed
consent elements can be found in the IRBNet "Forms and
Templates" library in IRBNet.

As a condition of ISU's IRB Registration and Federal-wide
Assurance (FWA) through the U.S. Department of Health and Human
Services, all individuals conducting human subjects research
must complete training. ISU has contracted with the University
of Miami to make this training available on-line.

The University of Miami training consists of two research tracks
(Biomedical and Social & Behavioral). IRB members, Principal
Investigators, and co-PIs may select the track most appropriate
to their research role and complete the required modules for the
chosen track.
To begin training go to
http://www.citiprogram.org/

Depending on the scope of research, the IRB may require that you
take additional modules relevant to the proposed work.

For training to be complete, the entire module sequence must be
completed with a combined score of at least 70%. You can
register for and complete the training at http://www.citiprogram.org/

Please note that you will need to upload a copy of your CITI
training certificate into the IRBNet submission system as part
of your application.
Instructions for obtaining a copy of your certificate can be
found in the IRBNet
"Forms and Templates" library.
If you have technical difficulties with the on-line
training, please contact the Office of Sponsored Programs at
(812) 237-8124.

Exempt:
Research activities in which the involvement of human subjects
constitutes no more than minimal risk and falls within one or more
of the exemption categories described in 45 CFR 46 101 (see Form
B in the "Form and
Templates" library in IRBNet) may be eligible for exemption certification. A designated IRB
member determines exemption certification.

Expedited:Research activities in which the involvement of human
subjects involves no more than minimal risk and falls within one or
more of the expedited review categories (see Form C
in the "Form and
Templates" library in IRBNet) may be
eligible for expedited review. An expedited review is conducted by
the IRB Chairperson or Vice Chairperson and a designated IRB member.

Full:Research activities in which the involvement of human
subjects involves more than minimal risk and does not fall within
one or more of the exemption categories ((see Form
B in the "Form and
Templates" library in IRBNet) or expedited
review categories (see Form C
in the "Form and
Templates" library in IRBNet ), or involves certain
vulnerable populations (e.g. prisoners) must undergo a review. A
full review is conducted by entire IRB committee.

7. Is there a deadline by which I must submit my application to the
IRB?

The IRB accepts applications on a
year-round basis. The only deadlines are for
protocols receiving full reviews. PIs need to submit
full protocols by the deadline listed on the IRB
Meeting Schedule in order for their application
to be reviewed at the next meeting.

8. Do I need to submit an application to ISU's IRB if I'm conducting
my study at another university?

Yes. PI(s) at ISU who are conducting
research at another institution are required to
abide by ISU requirements, as well as, the
requirements of the other institution. The PI will
need to request a letter of approval from the other
institution stating that the research may be
conducted at the site and that those at the site
agree to comply with ISU's IRB requirement for the
protection of human subjects. If the other
institution has an IRB, the PI may be required to
seek its approval as well, or file a request to
designate one of the institutions' IRB to review the
research (e.g. IRB authorization agreement).
{Excerpt
from Section I. of ISU IRB Policies and Procedures
Manual.}

9. Do researchers who are not associated with ISU need to submit an
application to ISU's IRB in order to conduct their research at ISU?

When ISU is considered to be "engaged
in research" (see OHRP guidance document "Engagement of Institutions in
Research," October 16, 2008) but the PI is not associated with ISU, the
PI must submit the following for review by the IRB: an application (Form
A, and B or C, if applicable), a letter of support from a faculty member
or EAP staff member at ISU who will sponsor the project, and a letter of
approval from IRB of the institution where the individual is at, unless
the individual's institution does not have an IRB.The IRB will then complete the appropriate
review of the PI's IRB, in which case both
institutions would need to complete the IRB
authorization agreement. When ISU is not "engaged in
the research, "the unaffiliated PI needs to obtain
IRB approval at his or her institution and secure
permission from an ISU office (e.g. department
chairperson, dean, supervisor) to conduct the study
at ISU.

After you have successfully submitted
your application via IRBNet, a Submission
Confirmation page will appear. If your application
is incomplete, signatures from the appropriate
faculty/staff sponsor and/or administrator were not
provided electronically through the IRBNet system,
or key personnel have not met the IRB's training
requirements, you will receive a message through
IRBNet that states that your application cannot be
reviewed by the IRB until the issues are resolved.

11. How long does it take for the IRB to approve my application or
to determine it's exempt?

While there is no specific timeline,
you are supposed to receive information regarding
the status of your application within 10 business
days (two work weeks) of submitting a complete
application within IRBNet. That does not mean that
your application will be approved or determined to
be exempt within that time frame, as sometimes the
IRB may request clarification or revisions.

You cannot begin recruitment until
after the date that an official letter from the IRB
is posted within IRBNet. If you begin your
recruitment prior to an official letter from the IRB
being is posted within IRBNet (either approval or
exempt determination), then you will be in
noncompliance with IRB Policy.

14. Can I conduct
research using my own students as research subjects?

ISU does not normally allow students to participate
in a research study conducted by a PI from whom they
are currently taking classes except under the
exemption categories {45 CFR 46.101 (b) (1)}. If the
nature of the study or other circumstances makes it
impossible to conduct the study without using one's
own students, the IRB may consider exceptions on an
individual basis. The preferred method is to have
data collected by an independent third party (e.g.,
colleague in own or other department), in such a way
that the instructor does not know the identity of
the participants and does not have access to
identifiable data until final course grades have
been assigned and entered. In addition, the
researcher will need to complete the form titled
"Form S" (found in the IRBNet "Forms and Templates")
and upload it into the IRBNet system along with the
other required application documents.Refer to Section P, "Students as Research
Subjects", of the ISU IRB Policies and
Procedures manual for more requirements on using
students.

15. How do I request changes to a project that has already been
approved?

If your study originally was approved following an
expedited or full review, you must submit Form D
(found in the IRBNet "Forms and Templates" library)
and obtain IRB approval via IRBNet prior to
implementing any changes to the research project's
protocol, informed consent, or assent forms. See IRB
Policy and Procedures Manual section F.1.2.2 and
F.1.3.2 for more information.

Some changes to exempt
protocols, depending on the level of risk, may
require IRB approval. Please contact the Office of
Sponsored Programs (812) 237-8124 for more details.

Typically, the IRB approves a research study or
continuation request for one year. However, approval
may be granted for less than one year in some
circumstances, which may include, but are not
limited to, high-risk protocols, projects involving
unusual risk to subjects, projects involving
vulnerable subjects (e.g., prisoners), and projects
conducted by a PI who has previously failed to
comply with IRB requirements.

Continuation reviews are not required for studies
determined to be exempt.

17.I am
planning to conduct a human subjects research project in a foreign
country. Are there any laws, regulations or guidelines that I
should be aware of in that regard?

A human subjects research project conducted in a
foreign country still requires approval though our
IRB. The federal Office for Human Research
Protections (OHRP) has developed an International
Compilation of Human Subject Research Protections.
This compilation lists the laws, regulations, and
guidelines of over 50 countries. The
compilation can be accessed on the OHRP website at:
www.hhs.gov/ohrp/international/HSPCompilation.pdf.

To use the Compilation, go to page 3 of the document
and then click on the country of interest.

18.I am conducting a grant-funded project and one of the
requirements of the funding agency is to evaluate the success or
effectiveness of the project and report back to the agency. Do the
data collection activities I will used for project evaluation
purpose require IRB review and approval?

If the intended use of the data collected is solely
for reporting back to the funding agency as a basis
for evaluating the project, then the associated data
collection activities typically do not require IRB
review and approval (keep in mind that there are
some federal agencies, such as the Centers for
Disease Control (CDC), that may require evaluative
data collection activities to receive IRB review and
approval).

However, the IRB recognizes that there may be
situations where you want to use the evaluation data
for research purposes or to collect additional data
from your project participants strictly for research
purposes. In these situations, IRB review and
approval of the research-related aspects are
required. In either case (use of evaluation
data for research or collection of additional data
strictly for research) your consent document(s)
should clearly differentiate the evaluation
components (for which participation is generally
mandatory) from the research related components (for
which participation in or use of collected
evaluation data is voluntary).